FDA debates guidelines for birth defect-causing acne drug

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WASHINGTON — Every patient given the acne drug Accutane must be enrolled in a national registry as part of major new steps to prevent pregnancy among women using the birth defect-causing medicine, government advisers said Friday.

Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

The registry system would mandate that women cannot get their monthly supply of Accutane without a negative pregnancy test, and that they be told to use two forms of contraception while taking the drug.

Every health worker who prescribes Accutane and every drugstore that dispenses it must be registered, too — and the drugstores must double-check that women are properly cleared before handing over the pills, said scientific advisers to the Food and Drug Administration.

Drug linked to severe birth defects
If a woman becomes pregnant while taking Accutane or generic isotretinoin, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. There’s a risk for 30 days after stopping the drug, too.

In 2001, the FDA began urging pregnancy testing and contraceptive education before doctors prescribed Accutane, but it’s a voluntary system that the agency acknowledges has failed to reduce pregnancies.

FDA isn’t bound by its advisers’ recommendations but typically follows them and pledged a quick decision.

“Doing nothing and making no change is really not acceptable,” said FDA’s Dr. Sandra Kweder.

Accutane manufacturer Hoffman-La Roche Inc. and makers of the generic version, called isotretinoin, support a registry.

Quick implementation of registery urgedUnder the plan, users of all forms of isotretinoin would be listed under a single nationwide registry. Men would be listed, too, because it’s important that they understand not to share an Accutane prescription with any women.

Even with the new curbs, pregnancies won’t be eliminated, FDA’s advisers cautioned.

“There’s a certain limit to what we can do,” said Dr. Robert Katz, a Rockville, Md., dermatologist who told of a patient who insisted with each monthly Accutane prescription that she wasn’t sexually active — until the day she called him in a panic that she’d missed a menstrual period.

“You can’t completely control human behavior,” he said.

Part of the problem is that Accutane is prescribed too often, said FDA adviser Dr. Eileen Ringel, a Waterville, Maine, dermatologist. It is intended for people with very severe acne, the kind that causes large cysts and leaves deep scars, yet “females are being treated for less severe acne with Accutane,” she said.

The advisers urged quick implementation of the registry, citing mothers who pleaded with the panel for better protections.

'Warning is simply not enough'“Warning is simply not enough,” said Debbie Banner of Virginia Beach, Va., who said another side effect of Accutane — depression — can lead women to disregard or not understand the need for contraception. She blames a drug-caused bout of severe depression on unprotected sex while using Accutane.

“I was devastated that I played a role in my own son being deformed,” said Banner, whose 7-year-old has serious brain damage.

Accutane has posed a birth-defect problem since it first hit the market in 1982.

The FDA has well over 2,000 reports of women on isotretinoin becoming pregnant since then. The vast majority opted for abortion. While some healthy babies were born, the FDA counts more than 160 babies born with Accutane-caused birth defects in that time — although critics note there could be many more left uncounted, because doctors aren’t required to report Accutane-linked pregnancies to the agency.

Warning after warning to doctors and patients didn’t help, so in 2001 the FDA’s advisers recommended a registry.

Citing legal concerns about privacy, the FDA settled on voluntary restrictions instead. But in the first year of those voluntary curbs, FDA counted 120 pregnancies among Accutane users, just seven fewer than in the previous year — even though overall prescriptions dropped by 23 percent.